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Novartis Suspends Distribution of Seasonal Flu Vaccines Agriflu and Fluad in Canada as a Precaution

Starting date:
October 26, 2012
Type of communication:
Information Update
Subcategory:
Vaccines
Source of recall:
Health Canada
Identification number:
RA-15096

Information Update
2012-162
October 26, 2012
For immediate release

Notice to the reader: This document has been updated by an information update dated October 31, 2012.

OTTAWA - Health Canada would like to provide further information to Canadians about its assessment of the voluntary suspension of use in Europe of the seasonal flu vaccines Agriflu and Fluad.

Agriflu and Fluad are two of the seasonal flu vaccines produced by Novartis that have been pulled from use in several European countries pending further examination of white floating material discovered clumping in the vaccines.

Health Canada rigorously reviewed Agriflu and Fluad for safety and effectiveness before it was authorized for use in Canada

Clumping of the kind noted in Europe is common in vaccines. Health Canada has previously seen such particles before in other vaccines and has observed no impact on their safety or effectiveness. The Public Health Agency of Canada monitors for adverse events following immunization. To date it has received no reports of serious or unexpected adverse events related to these vaccines.

As a precautionary step, Health Canada asked Novartis to suspend distribution of the vaccines in Canada until a full review of the situation is completed. Novartis has agreed. The Public Health Agency of Canada is also recommending that health care professionals in possession of these vaccines refrain from using them until the review is complete.

The Public Health Agency of Canada and Health Canada will continue to work with the company to monitor the safety and effectiveness of the vaccine used here in Canada. Should a safety concern be identified, immediate and appropriate action will be taken.

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